ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation

Limbal Stem Cell Deficiency Clinical Trial

Official title:

ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation Expanded in Vitro on Amniotic Membrane in Patients With Limbal Stem Cell Deficiency.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02579993
• Other study ID #: CI-051-2014
• Status: Terminated
• Phase: N/A
• First received: October 11, 2015
• Last updated: March 5, 2018
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.

Description:

There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Bilateral limbal stem cell deficiency of any etiology.

2. Corneal impression cytology positive for goblet cells.

3. Ocular ultrasound results within normal parameters.

4. Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Active immunological diseases.

Related Conditions & MeSH terms

• Limbal Stem Cell Deficiency

Intervention

Procedure:
• Pannus and conjunctival dissection
A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.
• Human cultivated limbal stem cell transplantation
The amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured.

Locations

Country	Name	City	State
Mexico	Instituto de Oftalmologia Conde de Valenciana	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective clinical evaluation	A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.	6 months
Primary	Objective clinical evaluation	A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.	12 months
Secondary	Corneal cells morphology	Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology	6 months
Secondary	Corneal cells morphology	Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology	12 months
Secondary	Quality of life questionnaire	Modified National Eye Institute Visual Function Questionnaire 25 questionnaire	6 months
Secondary	Quality of life questionnaire	Modified National Eye Institute Visual Function Questionnaire 25 questionnaire	12 months
Secondary	Visual acuity	Visual acuity in the Logarithm of the Minimum Angle of Resolution scale	6 months
Secondary	Visual acuity	Visual acuity in the Logarithm of the Minimum Angle of Resolution scale	12 months